TRAMADOL HCL ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Tramadol Hydrochloride.
| Product ID | 61919-818_87fe2c8f-0295-48c8-e053-2995a90aebe7 |
| NDC | 61919-818 |
| Product Type | Human Prescription Drug |
| Proprietary Name | TRAMADOL HCL ER |
| Generic Name | Tramadol Hcl |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-05-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA200503 |
| Labeler Name | DIRECT RX |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CIV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-05-03 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA200503 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-05-03 |
| Marketing Category | ANDA |
| Application Number | ANDA200503 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-05-03 |
| Ingredient | Strength |
|---|---|
| TRAMADOL HYDROCHLORIDE | 100 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 51655-182 | Tramadol HCl | Tramadol HCl |
| 61919-818 | TRAMADOL HCL | TRAMADOL HCL |
| 80425-0057 | Tramadol HCL | Tramadol HCL |
| 80425-0058 | Tramadol HCL | Tramadol HCL |
| 80425-0101 | Tramadol HCL | Tramadol HCL |
| 80425-0108 | Tramadol HCL | Tramadol HCL |
| 80425-0127 | Tramadol HCL | Tramadol HCL |
| 80425-0136 | Tramadol HCL | Tramadol HCL |
| 80425-0141 | Tramadol HCL | Tramadol HCL |
| 80425-0159 | Tramadol HCL | Tramadol HCL |
| 51655-185 | Ultram | TRAMADOL HCL |